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Biology
B3
developing drugs
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Cards (46)
What is constantly being developed in the pharmaceutical field?
New
drugs
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What must new drugs undergo before being given to the public?
They must go through a
thorough testing procedure
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What are the three main stages in drug testing?
Preclinical
testing on human cells and tissues
Testing on animal models for
efficacy
and
toxicity
Clinical trials
on human volunteers
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In preclinical testing, where are drugs fastened?
On
human cells
and tissues in the lab
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Why can't human cells and tissues be used to test drugs affecting whole body systems?
Because
they do not represent whole body systems
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What is required for testing drugs that affect blood pressure?
Testing must be done on a whole
animal
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What is the purpose of testing on dragon animals?
To evaluate
drug efficacy
and
toxicity
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What does testing on dragon animals help to find out?
Drug efficacy
,
toxicity
, and best
dosage
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What is the significance of the optimal dose found during testing?
It is the most
effective
dose with few side effects
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What happens to drugs that pass the tests on healthy volunteers?
They can be tested on
patients
with conditions
They are evaluated for
safety
and
efficacy
They may enter the market if successful
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What is the law in Britain regarding new drugs?
They must be tested on
different
live
mammals
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What do some people believe about testing drugs on animals?
They
believe
it is the
safest
way to ensure
drug
safety
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What happens if a drug passes all tests on animals?
It can be tested on human
volunteers
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What is the first step in clinical trials?
Testing the drug on
healthy volunteers
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Why are healthy volunteers used in the first step of clinical trials?
To ensure the drug has no
harmful
side effects
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What happens at the start of a clinical trial regarding drug dosage?
A very
low dose
of the drug is given
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How is the dosage increased during clinical trials?
The dosage is
gradually
increased
over time
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What happens if the results of the tests on healthy volunteers are good?
The drugs can be tested on
patients
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What is the optimal dose found during testing?
It is the most
effective
dose with few
side effects
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What is the process of randomization in clinical trials?
Patients are randomly assigned to groups
One group receives the drug, the other a
placebo
This helps eliminate bias in results
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What is the purpose of randomization in clinical trials?
To
eliminate
bias
in results
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What happens to patients in clinical trials?
They are
randomly assigned
to two groups
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What is the significance of having one group receive a placebo?
It helps to compare the
drug's
effects accurately
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What is the outcome if the drug works well in trials?
It can be
approved
for public use
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What is the goal of drug testing on humans?
To ensure
safety
and
efficacy
before market
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How does the testing process ensure drug safety?
By evaluating effects on both
animals
and
humans
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What are the key considerations in drug testing?
Efficacy
of the drug
Safety and
side effects
Optimal
dosage
for effectiveness
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What can drugs be tested on?
People suffering from
illness
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What is the optimal dose of a drug?
The most
effective dose
with few
side effects
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How are patients assigned in drug testing?
Randomly
into
two
groups
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What happens to one group in a drug trial?
They receive the new drug being
tested
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What does the other group in a drug trial receive?
A
placebo
that mimics the drug
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Why is it important for doctors to see the actual difference in drug effects?
To monitor the drug's
effectiveness
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What do patients expect from the treatment?
That it will work and improve their
condition
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What are clinical trials?
Studies where patients don't know the
treatment
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What do patients not know in a blind trial?
Whether they are receiving the
drug
or placebo
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Why might results not be published immediately?
They need to be reviewed by
peers
first
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What does peer review ensure?
The
validity
and
reliability
of the research
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What does the placebo effect refer to?
Improvements due to
patient expectations
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What is the significance of the placebo effect in trials?
It helps distinguish
drug effects
from expectations
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